Early Metabolic Changes with Thiazide or Beta Blocker Therapy for Essential Hypertension
| ISRCTN | ISRCTN06257223 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06257223 |
| Secondary identifying numbers | N0544160627 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 17/04/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Morris J Brown
Scientific
Scientific
Box No 110
Dept. of Clinical Pharmacology
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 762574 |
|---|---|
| mjb14@medschl.cam.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Can the oral glucose tolerance test detect changes after 4 weeks treatment with thiazide diuretics or beta blockers or combination of the two? |
| Ethics approval(s) | Added 5 August 2008: approved by Cambridge Research Ethics Committee on 26/11/04. |
| Health condition(s) or problem(s) studied | Hypertension |
| Intervention | Drug(s) vs placebo. Blood samples for glucose and insulin determination. Collected by Research team/CIW staff. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Atenolol, bendrofluazide |
| Primary outcome measure | Change in 2 hour glucose between any drug/drug combination versus placebo. |
| Secondary outcome measures | Added 5 August 2008: 1. Do patients show a similar change in glucose tolerance after thiazide or beta blocker treatment? 2. Does the combination of drugs cause a greater reduction in glucose tolerance than expected from the response to each drug alone? |
| Overall study start date | 01/02/2005 |
| Completion date | 01/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Pilot: 12, main study: 66 |
| Key inclusion criteria | Non-diabetic patients who are diagnosed as having essential hypertension will be recruited. We will be comparing the two most commonly used drugs to treat hypertension, atenolol and bendrofluazide, in patients for whom the drugs (and the doses to be used) are licenced. We propose an initial open label pilot study of 10-12 patients to confirm final doses to be tested, the duration of therapy for optimum timing of the OGTT and tolerability of doses selected. The pilot study will also be used to confirm sample size calculations for the main study. The protocol for the pilot study will be identical to the main study, but there will not be a placebo phase and the treatment will not be blinded. The main study will be double-blind, placebo controlled, cross-over study, of approximately 66 patients in which each patient receives in random order, 4 weeks treatment with either Bendrofluazide 5-10mg daily, Atenolol 50-100mg daily or combination of Bendrofluazide 2.5-5mg and Atenolol 25-50mg daily. There will be a forced titration from the lower to the higher dose stated half way through each dosing period. There will be a 1 month placebo wash-out between each dosing period. At 0, 2 and 4 weeks of each treatment phase, patients will attend the Clinical Investigation Ward (CIW), fasting, for performance of an oral glucose tolerance test (OGTT). Blood will be drawn from an intravenous cannula, for the measurements of glucose and insulin at 0, 1 and 2 hours. Blood pressure will be measured at each study visit using an Omron machine. The patients will also be given a blood pressure machine to take home and will be asked to measure and record their blood pressure at least twice per week. If their blood pressure is under 110/70mmhg or over 160/110mmHg at any time or if the patient has symptoms e.g. headache or dizziness, the patient will be asked to contact study staff. If the blood pressure remains over 160/110 for two measurements, then another antihypertensive therapy may be commenced, or the patient withdrawn from the study. If blood pressure is < 110/70 mmHg with symptoms then a decision may be made to terminate their participation in the study. The doses of drugs to be used, while commonly used for angina and oedema, are higher than now commonly used for hypertension. We expect them to be well tolerated during short term use. These doses have also been chosen because they will enable genetic studies top be performed subsequently in a large number of patients. Prof M Brown and Clinical Pharmacology Unit team has experience of many research studies in the treatment of hypertension. The design of this study has been derived partly from previous experience from these studies and from patient suggestions from these studies. |
| Key exclusion criteria | 1. Any patient already taking thiazide diuretics or beta blockers in whom these drugs cannot be switched to alternative drugs with similar or better blood pressure control. 2. Any patient who is intolerant of these medications will be excluded from the study. |
| Date of first enrolment | 01/02/2005 |
| Date of final enrolment | 01/02/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Box No 110
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Cambridge Consortium - Addenbrooke's (UK) - NHS Research and Development Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2012 | Yes | No |
